This invention relates generally to an improved artificial sphincter system for the control of excretory body passages, and more specifically to a device and method for treating incontinency utilizing lifting means for reversibly occluding and/or repositioning said body passages.
The artificial sphincters for treating incontinence which are known or described in the art often employ a distally located fluid reservoir, usually of the balloon or bulb type, which in conjunction with one or more pumps serves to transfer fluid into or out of an inflatable cuff which is disposed about the body passageway to be occluded. When the cuff is inflated, the body passageway is occluded; when it is deflated the body passageway is opened and excretion occurs. It is also the norm that these basic components, that is, cuff, pump means, and reservoir are connected by means of lumens or fluid transmission passageways. Typically one fluid transmission passageway connects the cuff with the pump while a second transmission passageway connects the pump with the reservoir.
The location of the balloon type reservoirs are of particular concern in the known artificial sphincter systems. This is because reservoirs of this type tend to be rather large, particularly in proportion to the other components of the system. Because of their size, they are usually located in areas of the body which have room for such implantation. In most instances this will be in the abdomen. However, to implant bulb or balloon reservoirs in the abdomen necessitates rather complex surgery which can be debilitating particularly to the elderly. Moveover, abdominal surgery also incurs a fairly high risk of postoperative infection and is almost always rather long in duration, requiring a fairly lengthy postoperative healing period due to the trauma to which the body has been subjected. It is apparent that it would be highly desirable to avoid abdominal surgery and in general to reduce the complexity of the implantation procedures for artificial sphincters.
In order to prevent female urine incontinence the cuff or other occlusion means is usually disposed about the bladder neck, i.e. in the proximal vicinity of the urethra. In the case of males, the cuff is usually placed either about the bladder neck and the bulbous urethra. Using this type of device the urethra is physically closed by the pressure of the cuff. The natural method of maintaining continence does not involve compressive forces around the exterior of the urethra, but rather the lifting or dropping of the position of the bladder neck. The cuff devices tend to cause tissue damage (tissue necrosis) of the urethra wall. Particularly if a bladder is capable of reflective contraction, the cuff type artificial sphincter must be used with extreme care. To maintain the continent state in the face of increased vesicle pressure requires a very large compressive force around the urethra. The resulting forces can produce tissue damage to the patient. While this is not a common occurrence, when it does occur it can result in the need for a serious operation necessitating the removal of the cuff. Of course incontinence continues. Similarly the constricting efficiency of the cuff can be diminished significantly if the urethra wall occluded by the cuff begins to undergo necrosis and atrophy.
Another method of treating incontinence, particularly female stress incontinence, involves suspension of the bladder neck or, in the care of male patients suspension of the membranous urethra. The purpose of this suspension procedure is to achieve continence by lifting and fixating the position of the urethrovesical junction or proximal urethra to that point where the urethra is closed. A major problem encountered during these procedures is the difficulty in obtaining the correct positioning of the bladder neck or proximal urethra so that such positioning is sufficiently high to avoid incontinence without causing obstruction or urine retention.
In U.K. Patent No. 1,174,814 there was provided a device for the occlusion and release of an artificially constructed duct. A sling for this purpose is provided which is tightened by a mechanical device and is released by a spring. No lifting is involved.
U.S. Pat. No. 4,118,805 discloses a mechanical sphincter which may be adjusted after implantation. No sling or lifting action is proposed in the patent.
It would be very desirable to have a device whereby if a patient does not wish to void, or does not have to, he or she can raise the urethra or bladder neck by means of a device such as a sling to a point whereby continence is reasonably guaranteed, but wherein when there is a desire or need to void, he or she can lower the urethra or bladder neck voluntarily to a position where voiding can occur. If the need for a cuff can also be thereby alleviated, this would also be very advantageous.
It would also be desirable to provide an apparatus for maintaining continence which did not significantly damage the tissues of the bladder, urethra or surrounding areas.